System and method for patient data processing during diagnosis and therapy

ABSTRACT

A system and method for patient data processing during diagnosis and therapy of a patient&#39;s sleep disorder breathing. The system and method includes providing diagnostic providers and therapy device providers with a simple and fast way to generate a clinical diagnosis from a diagnostic device and to transfer that patient&#39;s record and diagnostic data to the therapy provider responsible for the patient&#39;s ongoing care. The patient may be automatically assigned therapy devices having predetermined therapy settings that are based on the patient&#39;s record and diagnostic data.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a national phase entry under 35 U.S.C. § 371of International Application No. PCT/AU2014/050268 filed Oct. 3, 2014,published in English, which claims priority from Australian ApplicationNo. 2013903830 filed Oct. 4, 2013, all of which are incorporated hereinby reference.

1 BACKGROUND

1.1 Field of the Technology

The present technology relates to the diagnosis and treatment ofrespiratory-related disorders.

1.2 Description of the Related Art

1.2.1 Human Respiratory System and its Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe air into the venous blood and carbon dioxide to move out. Thetrachea divides into right and left main bronchi, which further divideeventually into terminal bronchioles. The bronchi make up the conductingairways, and do not take part in gas exchange. Further divisions of theairways lead to the respiratory bronchioles, and eventually to thealveoli. The alveolated region of the lung is where the gas exchangetakes place, and is referred to as the respiratory zone. See“Respiratory Physiology”, by John B. West, Lippincott Williams &Wilkins, 9th edition published 2011.

A range of respiratory disorders exist. Some examples of respiratorydisorders include: Obstructive Sleep Apnea (OSA), Cheyne StokesRespiration (CSR), Obesity Hyperventilation Syndrome (OHS). ChronicObstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) orchest wall disorders.

Otherwise healthy individuals may take advantage of systems and devicesto prevent respiratory disorders from arising.

1.2.2 Diagnosis and Therapy

Patients' interaction with the health system generally comprises twomain stages or phases—a diagnostic stage and a treatment (also referredto as “therapy”) stage.

During the diagnostic stage a patient is tested and the patient'scondition is diagnosed. In the area of sleep and respiratory disorders,the diagnostic providers, as well as the therapy providers can bequalified medical practitioners, also referred to as physicians ordoctors, or assisting practitioners referred to as clinicians. Insteadof conducting a sleep test in a sleep lap or sleep clinic, a diagnosticproviders increasingly use portable take home testing devices todiagnose patients with sleep disorder breathing. Once the patient isdiagnosed, they may be put on a suitable therapy.

The application of the respiratory therapy defines the therapy stage,during which the patient is treated for the purpose of managing thepatient's condition and/or ameliorating its symptoms. The services tosupply the CPAP devices used for such therapy and monitor the progressof the patient's therapy may be provided by a therapy providerorganisation, such as a Home Medical Equipment (HME) company. A therapyprovider from the therapy provider company, such as a therapy clinician,may configure the device as per directions from the prescription, andput the patient on a program to monitor their ongoing adherence totherapy and the patient's therapy progress. For example, patientssuffering from sleep apnea may be diagnosed via a Home Sleep Test by adiagnostic provider and prescribed a therapy device, such as acontinuous positive airway pressure (“CPAP”) device, for homerespiratory therapy that is prescribed to operate at a particularpressure. The therapy provider for this patient will provide the deviceand set the required pressure and other settings. Alternatively, thetherapy device may be configured for automatic initial setup, based onthe prescription settings in the diagnostic prescription issued by thediagnostic provider.

Thus, the therapy provider may be responsible for setting the patientfor therapy. This may involve selection of a treatment mask, humidifier,conduits and other accessories, which may or may not be specified in theprescription issued by the diagnostic provider. Apart from the initialsetup, the therapy provider will also monitor the therapy data from thepatient therapy sessions. If the patient's therapy progress isunsatisfactory or there are other problems with the therapy, the therapyprovider may refer the patient back to the diagnostic provider forreview and modification to the therapy.

Insurance companies, or other assessing or reimbursing entity computer103, often require evidence that the patient has been diagnosed in anappropriate manner before paying for the diagnosis. In order for adetermination to be made of whether a patient was appropriatelydiagnosed, a diagnostic provider will need to present the appropriatedata from a Home Sleep Test device (which will also be referred to inthis specification as a diagnostic device) and a diagnosis needs to bemade available that is signed by a qualified physician. Furthermore,insurance companies often want to track whether a patient once diagnosedwith a medical condition successfully proceeds to and remains on thetherapy for which they are prescribed. This process can be inefficientand time consuming, with very poor patient traceability during thetransfer of the patient between the diagnostic and therapy provider. Thetransfer may be inconvenient and disruptive, because multiple records ofthe patient (e.g. one during the diagnostic stage patient management andanother one during the therapy stage) are being created on differentsoftware packages and in different software environments. Thecommunication between the two stages also currently involves paperrecords and/or faxed documents. This may cause inconvenience to thepatients and the diagnostic and therapy service providers, as well ascause errors in the patient's records.

1.2.3 Systems

A therapy system may comprise a Respiratory Pressure Therapy Device (RPTdevice), an air circuit, a humidifier, a patient interface, and datamanagement.

1.2.4 Patient Interface

A patient interface may be used to interface respiratory equipment toits user, for example by providing a flow of breathable gas. The flow ofbreathable gas may be provided via a mask to the nose and/or mouth, atube to the mouth or a tracheostomy tube to the trachea of the user.Depending upon the therapy to be applied, the patient interface may forma seal, e.g. with a face region of the patient, to facilitate thedelivery of gas at a pressure at sufficient variance with ambientpressure to effect therapy, e.g. a positive pressure of about 10 cmH2O.For other forms of therapy, such as the delivery of oxygen, the patientinterface may not include a seal sufficient to facilitate delivery tothe airways of a supply of gas at a positive pressure of about 10 cmH2O.

The design of a patient interface presents a number of challenges. Theface has a complex three-dimensional shape. The size and shape of nosesvaries considerably between individuals. Since the head includes bone,cartilage and soft tissue, different regions of the face responddifferently to mechanical forces. The jaw or mandible may move relativeto other bones of the skull. The whole head may move during the courseof a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being oneor more of obtrusive, aesthetically undesirable, costly, poorly fitting,difficult to use and uncomfortable especially when worn for long periodsof time or when a patient is unfamiliar with a system. For example,masks designed solely for aviators, mask designed as part of personalprotection equipment (e.g. filter masks), SCUBA masks or for theadministration of anesthetics may be tolerable for their originalapplication, but nevertheless be undesirably uncomfortable to be wornfor extended periods of time, e.g. several hours. This is even more soif the mask is to be worn during sleep.

Nasal CPAP therapy is highly effective to treat certain respiratorydisorders, provided patients comply with therapy. If a mask isuncomfortable, or difficult to use a patient may not comply withtherapy. Since it is often recommended that a patient regularly washtheir mask, if a mask is difficult to clean (e.g. difficult to assembleor disassemble), patients may not clean their mask and this may impacton patient compliance.

While a mask for other applications (e.g. aviators) may not be suitablefor use in treating sleep disordered breathing, a mask designed for usein treating sleep disordered breathing may be suitable for otherapplications.

For these reasons, masks for delivery of nasal CPAP during sleep form adistinct field.

1.2.4.1 Seal-Forming Portion

Patient interfaces may include a seal-forming portion. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming portion can have a direct impact the effectiveness andcomfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming portion is to engage with the face inuse. In one form of patient interface, a seal-forming portion maycomprise two sub-portions to engage with respective left and rightnares. In one form of patient interface, a seal-forming portion maycomprise a single element that surrounds both nares in use. Such singleelement may be designed to for example overlay an upper lip region and anasal bridge region of a face. In one form of patient interface aseal-forming portion may comprise an element that surrounds a mouthregion in use, e.g. by forming a seal on a lower lip region of a face.In one form of patient interface, a seal-forming portion may comprise asingle element that surrounds both nares and a mouth region in use.These different types of patient interfaces may be known by a variety ofnames by their manufacturer including nasal masks, full-face masks,nasal pillows, nasal puffs and oro-nasal masks.

A seal-forming portion that may be effective in one region of apatient's face may be in appropriate in another region, e.g. because ofthe different shape, structure, variability and sensitivity regions ofthe patient's face. For example, a seal on swimming goggles thatoverlays a patient's forehead may not be appropriate to use on apatient's nose.

Certain seal-forming portions may be designed for mass manufacture suchthat one design fit and be comfortable and effective for a wide range ofdifferent face shapes and sizes. To the extent to which there is amismatch between the shape of the patient's face, and the seal-formingportion of the mass-manufactured patient interface, one or both mustadapt in order for a seal to form.

One type of seal-forming portion extends around the periphery of thepatient interface, and is intended to seal against the user's face whenforce is applied to the patient interface with the seal-forming portionin confronting engagement with the user's face. The seal-forming portionmay include an air or fluid filled cushion, or a moulded or formedsurface of a resilient seal element made of an elastomer such as arubber. With this type of seal-forming portion, if the fit is notadequate, there will be gaps between the seal-forming portion and theface, and additional force will be required to force the patientinterface against the face in order to achieve a seal.

Another type of seal-forming portion incorporates a flap seal of thinmaterial so positioned about the periphery of the mask so as to providea self-sealing action against the face of the user when positivepressure is applied within the mask. Like the previous style of sealforming portion, if the match between the face and the mask is not good,additional force may be required to effect a seal, or the mask may leak.Furthermore, if the shape of the seal-forming portion does not matchthat of the patient, it may crease or buckle in use, giving rise toleaks.

Another type of seal-forming portion may comprise a friction-fitelement. e.g. for insertion into a naris.

Another form of seal-forming portion may use adhesive to effect a seal.Some patients may find it inconvenient to constantly apply and remove anadhesive to their face.

A range of patient interface seal-forming portion technologies aredisclosed in the following patent applications, assigned to ResMedLimited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in the Adam Circuit manufactured byPuritan Bennett. Another nasal pillow, or nasal puff is the subject ofU.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-BennettCorporation.

ResMed Limited has manufactured the following products that incorporatenasal pillows: SWIFT nasal pillows mask, SWIFT II nasal pillows mask.SWIFT LT nasal pillows mask, SWIFT FX nasal pillows mask and LIBERTYfull-face mask. The following patent applications, assigned to ResMedLimited, describe nasal pillows masks: International Patent ApplicationWO2004/073,778 (describing amongst other things aspects of ResMed SWIFTnasal pillows), US Patent Application 2009/0044808 (describing amongstother things aspects of ResMed SWIFT LT nasal pillows); InternationalPatent Applications WO 2005/063,328 and WO 2006/130,903 (describingamongst other things aspects of ResMed LIBERTY full-face mask);International Patent Application WO 2009/052,560 (describing amongstother things aspects of ResMed SWIFT FX nasal pillows).

1.2.4.2 Positioning and Stabilising

A seal-forming portion of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming portion, and to maintain it in sealingrelation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US Patentpublication US 2010/0000534.

Another technique is the use of one or more straps and stabilisingharnesses. Many such harnesses suffer from being one or more ofill-fitting, bulky, uncomfortable and awkward to use.

1.2.5 Respiratory Pressure Therapy (RPT) Device

One known RPT device used for treating sleep disordered breathing is theS9 Sleep Therapy System, manufactured by ResMed. Another example of anRPT device is a ventilator. Ventilators such as the ResMed Stellar™Series of Adult and Paediatric Ventilators may provide support forinvasive and non-invasive non-dependent ventilation for a range ofpatients for treating a number of conditions such as but not limited toNMD, OHS and COPD. RPT devices have also been known as flow generators.

The ResMed Elisée™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit.

RPT devices typically comprise a pressure generator, such as amotor-driven blower or a compressed gas reservoir, and are configured tosupply a flow of air to the airway of a patient. In some cases, the flowof air may be supplied to the airway of the patient at positivepressure. The outlet of the RPT device is connected via an air circuitto a patient interface such as those described above.

RPT devices typically also include an inlet filter, various sensors anda microprocessor-based controller. A blower may include aservo-controlled motor, a volute and an impeller. In some cases a brakefor the motor may be implemented to more rapidly reduce the speed of theblower so as to overcome the inertia of the motor and impeller. Thebraking can permit the blower to more rapidly achieve a lower pressurecondition in time for synchronization with expiration despite theinertia. In some cases the pressure generator may also include a valvecapable of discharging generated air to atmosphere as a means foraltering the pressure delivered to the patient as an alternative tomotor speed control. The sensors measure, amongst other things, motorspeed, mass flow rate and outlet pressure, such as with a pressuretransducer or the like. The controller may include data storage capacitywith or without integrated data retrieval and display functions.

Table of noise output levels of prior devices (one specimen only,measured using test method specified in ISO3744 in CPAP mode at10cmH₂O).

A-weighted sound Year Device name power level dB(A) (approx.) C-SeriesTango 31.9 2007 C-Series Tango with Humidifier 33.1 2007 S8 Escape II30.5 2005 S8 Escape II with H4i Humidifier 31.1 2005 S9 AutoSet 26.52010 S9 AutoSet with H5i Humidifier 28.6 20101.2.6 Humidifier

Delivery of a flow of breathable gas without humidification may causedrying of airways. Medical humidifiers are used to increase humidityand/or temperature of the flow of breathable gas in relation to ambientair when required, typically where the patient may be asleep or resting(e.g. at a hospital). As a result, a medical humidifier is preferablysmall for bedside placement, and it is preferably configured to onlyhumidify and/or heat the flow of breathable gas delivered to the patientwithout humidifying and/or heating the patient's surroundings.Room-based systems (e.g. a sauna, an air conditioner, an evaporativecooler), for example, may also humidify air that is breathed in by thepatient, however they would also humidify and/or heat the entire room,which may cause discomfort to the occupants.

The use of a humidifier with a flow generator or RPT device and thepatient interface produces humidified gas that minimizes drying of thenasal mucosa and increases patient airway comfort. In addition, incooler climates warm air applied generally to the face area in and aboutthe patient interface is more comfortable than cold air.

Respiratory humidifiers are available in many forms and may be astandalone device that is coupled to a respiratory apparatus via an aircircuit, is integrated with or configured to be coupled to the relevantrespiratory apparatus. While known passive humidifiers can provide somerelief, generally a heated humidifier may be used to provide sufficienthumidity and temperature to the air so that the patient will becomfortable. Humidifiers typically comprise a water reservoir or tubhaving a capacity of several hundred milliliters (ml), a heating elementfor heating the water in the reservoir, a control to enable the level ofhumidification to be varied, a gas inlet to receive gas from the flowgenerator or RPT device, and a gas outlet adapted to be connected to anair circuit that delivers the humidified gas to the patient interface.

Heated passover humidification is one common form of humidification usedwith a RPT device. In such humidifiers the heating element may beincorporated in a heater plate which sits under, and is in thermalcontact with, the water tub. Thus, heat is transferred from the heaterplate to the water reservoir primarily by conduction. The air flow fromthe RPT device passes over the heated water in the water tub resultingin water vapour being taken up by the air flow. The ResMed H4i™ and H5i™Humidifiers are examples of such heated passover humidifiers that areused in combination with ResMed S8 and S9 CPAP devices respectively.

Other humidifiers may also be used such as a bubble or diffuserhumidifier, a jet humidifier or a wicking humidifier. In a bubble ordiffuser humidifier the air is conducted below the surface of the waterand allowed to bubble back to the top. A jet humidifier produces anaerosol of water and baffles or filters may be used so that theparticles are either removed or evaporated before leaving thehumidifier. A wicking humidifier uses a water absorbing material, suchas sponge or paper, to absorb water by capillary action. The waterabsorbing material is placed within or adjacent at least a portion ofthe air flow path to allow evaporation of the water in the absorbingmaterial to be taken up into the air flow.

An alternative form of humidification is provided by the ResMedHumiCare™ D900 humidifier that uses a CounterStream™ technology thatdirects the air flow over a large surface area in a first directionwhilst supplying heated water to the large surface area in a secondopposite direction. The ResMed HumiCare™ D900 humidifier may be usedwith a range of invasive and non-invasive ventilators.

2 BRIEF SUMMARY OF THE TECHNOLOGY

The present technology relates to the diagnosis and treatment of sleepdisorder breathing patients and related respiratory insufficiencies.Currently, the diagnostic stage and the therapy stage of patientmanagement are somewhat disconnected and incoherent. What is needed isan integrated electronic system which links the diagnostic provider andtherapy provider to the same patient database, and allows for easygeneration, management, and transfer of a patient's diagnosticinformation directly to the prescribed flow generator (which will alsobe referred to in herein as a therapy device).

The present technology therefore relates to a method and system for anintegrated processing and management of the patient data during thediagnostic and therapy stages. In particular, the described systemprovides diagnostic providers and therapy device providers with a simpleand fast way to generate a clinical diagnosis from a diagnostic deviceand to transfer that patient's record and diagnostic data directly tothe therapy provider responsible for the patient's ongoing care.

In accordance with one aspect of the technology, a server containsmemory configured to store medical device data, and a processor incommunication with the memory.

The processor is configured to receive diagnostic and therapy data for aplurality of medical device users, and to process diagnostic report dataand therapy device usage data. A successful download of data may bebased on whether the received diagnostic data from the device contains apredetermined duration of recording information and conforms toacceptable clinical ranges. Therapy compliance may be based on whetherthe received medical device usage data satisfies predetermined usagecriteria, such as a number of hours of continuous usage or anotherpredetermined criterion.

The processor is also configured to receive a request from thediagnostic provider or health providers for the diagnostic stage, aswell as a compliance status for one or more of the patients usingmedical devices, and to transfer access to those patients from oneprovider to another.

In accordance with another aspect of the technology, a medical devicecan either be a Diagnostic Home Sleep Testing Device or a Therapy Device(e.g. a Flow Generator) used for respiratory therapy. In addition, thememory of the server may be further configured to store deviceidentifiers. e.g., a unique ID number, wherein the medical device datafor each of the plurality of medical device users includes a deviceidentifier, which may be a unique device identifier, and wherein theprocessor of the server is further configured to associate the medicaldevice usage data with a medical device user based on the receiveddevice identifiers.

In another aspect of the technology, the server's processor is furtherconfigured to regenerate medical device diagnostic data from at leastone of the plurality of medical device users, based on a user determinedchange in analysis parameters.

In another aspect, a clinical diagnostic summary report may be provided,the report being of a format that allows an assessing entity to acceptthe report as verification of diagnosis. For example, the report maycontain summary statistics from the diagnostic test data, a physician'sinterpretation of the test results and an electronic signature, as proofof review or acceptance.

In another aspect, a prescription based on a clinical diagnostic reportmay be provided. The prescription may be of a format that allows atherapy provider to supply a device, configure it for therapy and beginmonitoring a schedule for reimbursement. For example, the prescriptionmay contain a specified therapy device (e.g. CPAP), an itemised list ofaccessories (e.g. mask type), pressure settings for the device and anelectronic signature. This document may be used by a Therapy Provider tolegally supply the patient with the listed therapy items.

In another aspect of the technology, diagnostic and complianceindications are generated and displayed as selectable icons on thescreen of a user.

In another aspect, a compliance report may be provided. The report maybe of a formal that allows an assessing entity to accept the report asverification of compliance. For example, the report may contain anumerical or graphical indication of compliance.

In another aspect of the technology, a healthcare professionalassociated with a diagnostic provider may access a website and select onthe website one or more medical device users (patients) for whichdiagnostic information is available. The user may then select a therapyprovider from a list of eligible organizations within the system andsend the selected patients' diagnostic information to the selectedorganization. A user within the therapy provider will then receive anotification of the availability of diagnostic information for each ofthe one or more transferred medical device users, as well as theprescription information required to set up the patients on therapy.

In accordance with another aspect, a method for patient data processingduring diagnosis and therapy of sleep disorder breathing may beperformed. The method may include generating, by one or more computingdevices, an electronic patient record for a patient: during a diagnosticstage of the patient, storing, by the one or more computing devices,diagnostic-related data in the electronic patient record; providing, bythe one or more computing devices, a diagnostic medical practitionerwith access to the electronic patient record; during a therapy stage ofthe patient, providing, by the one or more computing devices, a treatingmedical practitioner with access to the electronic patient record; andupdating, by the one or more computing devices, the electronic patientrecord to include therapy-related data.

In another aspect, the method may include storing at least one ofreports and prescriptions, generated during either the diagnostic stageor the therapy stage, in the electronic patient record. When thediagnostic stage is at an end, the treating medical practitioner isnotified and provided access to at least one of diagnostic data andprescription data of the patient. Therapy settings from a therapyprescription may be retrieved from the electronic patient record andused to automatically configure a therapy device for the patient. Theautomatic configuration may be effected by way of a network connectionor a memory card. In addition, the data storage, processing, and accessduring the diagnostic stage and the therapy stage are performed on asingle software platform and on a single physical system of servers.

Once the electronic patient record is created, medical practitionersassociated with either the diagnostic stage or the therapy stage may beprovided access to the electronic patient record during both thediagnostic stage and the therapy stage. In addition, the diagnosticstage may include receiving data from a diagnostic device and thetherapy stage may include receiving data from a therapy medical device,the therapy medical device being a flow generator for respiratorytherapy.

In accordance with another aspect, a disclosed method may includereceiving, by one or more computing devices, medical device data for aplurality of medical device users; storing, by the one or more computingdevices, the medical device data; determining, by the one or morecomputing devices, whether to process the medical device data asdiagnostic information or as compliance information, based on apredetermined criterion related to identification data of the medicaldevices; if the medical device data is processed as diagnostic data,generating, by the one or more computing devices, diagnostic informationbased on predetermined analysis criteria; enabling, by the one or morecomputing devices, an electronic transfer of at least one of an clinicaldiagnosis report to an associated therapy provider, wherein thediagnosis report is based on the diagnostic information; andtransmitting, by the one or more computing devices, a therapy settingsto a therapy device associated with the diagnosis report.

In accordance with another aspect, receiving the medical device datafurther comprises receiving a signal that one of the medical devices hasdata available for uploading. In addition, the medical device may be ahome sleep testing device or a flow generator used for respiratorytherapy.

A generated diagnostic report may contain statistical indications whichassist diagnosis and provide an area where a healthcare professional mayinput their clinical interpretation. The diagnostic report may alsoinclude a prescription for therapy that identifies one or more therapydevices and one or more therapeutic settings to be used by a patient.The diagnostic report for therapy may be displayed as HTML on a webbrowser or as a Portable Document Format (PDF).

The method may also include assigning a therapy provider to a patientthat is ready for therapy; transferring diagnostic information for thepatient to the assigned therapy provider, and electronically importingtherapy settings from the diagnostic information onto the therapy deviceto be used by the patient.

In another aspect, an apparatus for integrated electronic management ofdiagnostic and therapy data of a plurality of sleep disorder breathingpatients may include: a memory configured to store medical data, and oneor more processors in communication with the memory. The one or moreprocessors may be configured to receive medical device data for aplurality of medical device users; associate the received medical devicedata with a corresponding patient records; determine whether receivedmedical device data is diagnostic or usage data; update the patientrecords in accordance with the determination of whether the receivedmedical device data is diagnostic or usage data; store a list of therapyproviders within a system of therapy providers; receive a request todisplay the list from a diagnostic provider, receive diagnostic datafrom the plurality of medical devices; generate summary statistics byprocessing the diagnostic data using a set of predetermined analysiscriteria; receive a request generated by a clinical user, and transmit,in response to the request, a diagnostic report comprising the summarystatistics.

The processors may also be configured to store a list of medical devicesand accessory items; receive a request to display the list by a clinicaluser; receive clinical settings information generated by the clinicaluser; receive text generated by the clinical user; transmit aprescription for therapy report displaying a selected item manifest andclinical settings; securely allow access to diagnostic and prescriptiondata of a patient record by the selected therapy provider; dynamicallyupdate the therapy provider's available patient list with at least onepatient record; display the additional patient record in the patientlist; securely display patient information, diagnostic reports andprescription for therapy reports as selected by a therapy provider user,receive a request to assign a patient with a therapy device ID thatcorresponds to the prescription; and automatically transfer clinicalsettings information into the memory from the prescription.

3 BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

3.1 Therapy Systems

FIG. 1A shows a system in accordance with the present technology. Apatient 1000 wearing a patient interface 3000, in the form of nasalpillows, receives a supply of air at positive pressure from a RPT device4000. Air from the RPT device is humidified in a humidifier 5000, andpasses along an air circuit 4170 to the patient 1000.

FIG. 1B shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receives a supply of air atpositive pressure from a RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1C shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receives a supply ofair at positive pressure from a RPT device. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

3.2 Therapy

3.2.1 Respiratory System

FIG. 2A shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

FIG. 2B shows a view of a human upper airway including the nasal cavity,nasal bone, lateral nasal cartilage, greater alar cartilage, nostril,lip superior, lip inferior, larynx, hard palate, soft palate,oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

3.2.2 Facial Anatomy

FIG. 2C is a front view of a face with several features of surfaceanatomy identified including the lip superior, upper vermillion, lowervermillion, lip inferior, mouth width, endocanthion, a nasal ala,nasolabial sulcus and cheilion.

3.3 Patient Interface

FIG. 3a shows an example of a patient interface known in the prior art.

3.4 Respiratory Pressure Therapy (RPT) Device

FIG. 4A shows a RPT device in accordance with one form of the presenttechnology.

FIG. 4B shows a schematic diagram of the pneumatic circuit of a RPTdevice in accordance with one form of the present technology. Thedirections of upstream and downstream are indicated.

FIG. 4C shows a schematic diagram of the electrical components of a RPTdevice in accordance with one aspect of the present technology.

3.5 Humidifier

FIG. 5A shows a humidifier in accordance with one aspect of the presenttechnology.

3.6 Breathing Waveforms

FIG. 6A shows a model typical breath waveform of a person whilesleeping, the horizontal axis is time, and the vertical axis isrespiratory flow. While the parameter values may vary, a typical breathmay have the following approximate values: tidal volume, Vt, 0.5 L,inhalation time. Ti, 1.6 s, peak inspiratory flow, Qpeak, 0.4 L/s,exhalation time, Te, 2.4 s, peak expiratory flow, Qpeak, −0.5 L/s. Thetotal duration of the breath, Ttot, is about 4 s. The person typicallybreathes at a rate of about 15 breaths per minute (BPM), withVentilation, Vent, about 7.5 L/s. A typical duty cycle, the ratio of Tito Ttot is about 40%.

3.7 Diagnosis and Therapy Data Management

FIG. 7 shows a system 100 that may be used in diagnosing and treating apatient's sleep disorder breathing. FIGS. 8-14 are various webpages thatmay be displayed in accordance with aspects of the disclosed system.

FIG. 15 is a schematic diagram of aspect of the disclosed system andmethods.

4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

4.1 Therapy Systems

In one form, the present system comprises an apparatus for treating arespiratory disorder. The apparatus may comprise a flow generator orblower for supplying pressurised respiratory gas, such as air, to thepatient 1000 via an air delivery tube leading to a patient interface3000.

4.2 Therapy

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

4.2.1 Nasal CPAP for OSA

In one form, the present technology comprises a method of treatingObstructive Sleep Apnea in a patient by applying nasal continuouspositive airway pressure to the patient.

4.3 Patient Interface 3000

A non-invasive patient interface 3000 in accordance with one aspect ofthe present technology comprises the following functional aspects: aseal-forming structure 3100, a plenum chamber 3200, a positioning andstabilising structure 3300, a vent 3400 and a connection port 3600 forconnection to air circuit 4170. In some forms a functional aspect may beprovided by one or more physical components. In some forms, one physicalcomponent may provide one or more functional aspects. In use theseal-forming structure 3100 is arranged to surround an entrance to theairways of the patient so as to facilitate the supply of air at positivepressure to the airways.

4.3.1 Seal-Forming Structure 3100

In one form of the present technology, a seal-forming structure 3100provides a sealing-forming surface, and may additionally provide acushioning function.

A seal-forming structure 3100 in accordance with the present technologymay be constructed from a soft, flexible, resilient material such assilicone.

In one form, the seal-forming structure 3100 comprises a sealing flangeand a support flange. Preferably the sealing flange comprises arelatively thin member with a thickness of less than about 1 mm, forexample about 0.25 mm to about 0.45 mm, that extends around theperimeter 3210 of the plenum chamber 3200. Support flange may berelatively thicker than the sealing flange. The support flange isdisposed between the sealing flange and the marginal edge of the plenumchamber 3200, and extends at least part of the way around the perimeter3210. The support flange is or includes a spring-like element andfunctions to support the sealing flange from buckling in use. In use thesealing flange can readily respond to system pressure in the plenumchamber 3200 acting on its underside to urge it into tight sealingengagement with the face.

In one form the seal-forming portion of the non-invasive patientinterface 3000 comprises a pair of nasal puffs, or nasal pillows, eachnasal puff or nasal pillow being constructed and arranged to form a sealwith a respective naris of the nose of a patient.

Nasal pillows in accordance with an aspect of the present technologyinclude: a frusto-cone, at least a portion of which forms a seal on anunderside of the patient's nose; a stalk, a flexible region on theunderside of the cone and connecting the cone to the stalk. In addition,the structure to which the nasal pillow of the present technology isconnected includes a flexible region adjacent the base of the stalk. Theflexible regions can act in concert to facilitate a universal jointstructure that is accommodating of relative movement—both displacementand angular—of the frusto-cone and the structure to which the nasalpillow is connected. For example, the frusto-cone may be axiallydisplaced towards the structure to which the stalk is connected.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on an upper lip region(that is, the lip superior) of the patient's face.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on a chin-region of thepatient's face.

4.3.2 Plenum Chamber 3200

Preferably the plenum chamber 3200 has a perimeter 3210 that is shapedto be complementary to the surface contour of the face of an averageperson in the region where a seal will form in use. In use, a marginaledge of the plenum chamber 3200 is positioned in close proximity to anadjacent surface of the face. Actual contact with the face is providedby the seal-forming structure 3100. Preferably the seal-formingstructure 3100 extends in use about the entire perimeter 3210 of theplenum chamber 3200.

In one form, the plenum chamber 3200 may surround and/or be in fluidcommunication with the nares of the patient where the plenum chamber3200 is a part of a nasal mask (e.g. shown in FIG. 1b ). In anotherform, the plenum chamber 3200 may surround and/or be in fluidcommunication with the nares and the mouth of the patient where theplenum chamber 3200 is a part of a full-face mask (e.g., shown in FIG.1C). In yet another form, the plenum chamber 3200 may engage and/or bein fluid communication with one or more of the nares of the patientwhere the plenum chamber 3200 is a part of nasal pillows.

4.3.3 Positioning and Stabilising Structure 3300

Preferably the seal-forming structure 3100 of the patient interface 3000of the present technology is held in sealing position in use by thepositioning and stabilising structure 3300.

4.4 RPT Device 4000

An example RPT device 4000 that may be suitable for implementing aspectsof the present technology may include mechanical and pneumaticcomponents 4100, electrical components 4200 and may be programmed toexecute one or more of the control methodologies or algorithms describedthroughout this specification. The RPT device may have an externalhousing 4010, preferably formed in two parts, an upper portion 4012 ofthe external housing 4010, and a lower portion 4014 of the externalhousing 4010. In alternative forms, the external housing 4010 mayinclude one or more panel(s) 4015. Preferably the RPT device 4000comprises a chassis 4016 that supports one or more internal componentsof the RPT device 4000. In one form a pneumatic block 4020 is supportedby, or formed as part of the chassis 4016. The RPT device 4000 mayinclude a handle 4018.

The pneumatic path of the RPT device 4000 preferably comprises an inletair filter 4112, an inlet muffler 4122, a controllable pressure device4140 capable of supplying air at positive pressure (preferably a blower4142), and an outlet muffler 4124. One or more flow sensors 4272 andpressure sensors 4274 are included in the pneumatic path.

The preferred pneumatic block 4020 comprises a portion of the pneumaticpath that is located within the external housing 4010.

The RPT device 4000 preferably has an electrical power supply 4210, oneor more input devices 4220, a central controller 4230, a therapy devicecontroller 4240 and/or any of the controllers previously described, apressure device 4140, one or more protection circuits 4250, memory 4260,transducers (also referred to as sensors) 4270, data communicationinterface 4280 and one or more output devices 4290. Electricalcomponents 4200 may be mounted on a single Printed Circuit BoardAssembly (PCBA) 4202. In an alternative form, the RPT device 4000 mayinclude more than one PCBA 4202.

The central controller 4230 of the RPT device 4000, which may includeone or more processors, can be programmed to execute one or morealgorithm modules, preferably including a pre-processing module, atherapy engine module, a pressure control module, and further preferablya fault condition module. It may further include a vent control modulethat may be configured with one or more of the vent controlmethodologies described throughout this specification.

4.4.1 RPT Device Mechanical & Pneumatic Components 4100

4.4.1.1 Air Filter(s) 4110

A RPT device in accordance with one form of the present technology mayinclude an air filter 4110, or a plurality of air filters 4110.

In one form, an inlet air filter 4112 is located at the beginning of thepneumatic path upstream of a blower 4142. See FIG. 4B.

In one form, an outlet air filter 4114, for example an antibacterialfilter, is located between an outlet of the pneumatic block 4020 and apatient interface 3000. See FIG. 4B.

4.4.1.2 Muffler(s) 4120

In one form of the present technology, an inlet muffler 4122 is locatedin the pneumatic path upstream of a blower 4142. See FIG. 4B.

In one form of the present technology, an outlet muffler 4124 is locatedin the pneumatic path between the blower 4142 and a patient interface3000. See FIG. 4B.

4.4.1.3 Pressure Device 4140

In a preferred form of the present technology, a pressure device 4140for producing a flow of air at positive pressure is a controllableblower 4142. For example the blower may include a brushless DC motor4144 with one or more impellers housed in a volute. The blower may bepreferably capable of delivering a supply of air, for example about 120litres/minute, at a positive pressure in a range from about 4 cmH₂O toabout 20 cmH₂O, or in other forms up to about 30 cmH₂O.

The pressure device 4140 is under the control of the therapy devicecontroller 4240.

4.4.1.4 Transducer(s) 4270

In one form of the present technology, one or more transducers 4270 arelocated upstream of the pressure device 4140. The one or moretransducers 4270 are constructed and arranged to measure properties ofthe air at that point in the pneumatic path.

In one form of the present technology, one or more transducers 4270 arelocated downstream of the pressure device 4140, and upstream of the aircircuit 4170. The one or more transducers 4270 are constructed andarranged to measure properties of the air at that point in the pneumaticpath.

In one form of the present technology, one or more transducers 4270 arelocated proximate to the patient interface 3000.

4.4.1.5 Anti-Spill Back Valve 4160

In one form of the present technology, an anti-spill back valve islocated between the humidifier 5000 and the pneumatic block 4020. Theanti-spill back valve is constructed and arranged to reduce the riskthat water will flow upstream from the humidifier 5000, for example tothe motor 4144.

4.4.1.6 Air Circuit 4170

An air circuit 4170 in accordance with an aspect of the presenttechnology is constructed and arranged to allow a flow of air orbreathable gasses between the pneumatic block 4020 and the patientinterface 3000.

4.4.1.7 Oxygen Delivery

In one form of the present technology, supplemental oxygen 4180 isdelivered to a point in the pneumatic path.

In one form of the present technology, supplemental oxygen 4180 isdelivered upstream of the pneumatic block 4020.

In one form of the present technology, supplemental oxygen 4180 isdelivered to the air circuit 4170.

In one form of the present technology, supplemental oxygen 4180 isdelivered to the patient interface 3000.

4.4.2 RPT Device Electrical Components 4200

4.4.2.1 Power Supply 4210

In one form of the present technology, power supply 4210 is internal ofthe external housing 4010 of the RPT device 4000. In another form of thepresent technology, power supply 4210 is external of the externalhousing 4010 of the RPT device 4000.

In one form of the present technology, power supply 4210 provideselectrical power to the RPT device 4000 only. In another form of thepresent technology, power supply 4210 provides electrical power to bothRPT device 4000 and humidifier 5000. The power supply may alsooptionally provide power to any actuator, controller and/or sensors fora vent arrangement as described throughout this specification

4.4.2.2 Input Devices 4220

In one form of the present technology, a RPT device 4000 includes one ormore input devices 4220 in the form of buttons, switches or dials toallow a person to interact with the device. These may be implemented forentering settings for operation of the components of the RPT device suchas the vent arrangement. The buttons, switches or dials may be physicaldevices, or software devices accessible via a touch screen. The buttons,switches or dials may, in one form, be physically connected to theexternal housing 4010, or may, in another form, be in wirelesscommunication with a receiver that is in electrical connection to thecentral controller 4230.

In one form the input device 4220 may be constructed and arranged toallow a person to select a value and/or a menu option.

4.4.2.3 Central Controller 4230

In one form of the present technology, the central controller 4230 is adedicated electronic circuit configured to receive input signal(s) fromthe input device 4220, and to provide output signal(s) to the outputdevice 4290 and/or the therapy device controller 4240.

In one form, the central controller 4230 is an application-specificintegrated circuit. In another form, the central controller 4230comprises discrete electronic components.

In another form of the present technology, the central controller 4230is a processor suitable to control a RPT device 4000 such as an x86INTEL processor.

A processor of a central controller 4230 suitable to control a RPTdevice 4000 in accordance with another form of the present technologyincludes a processor based on ARM Cortex-M processor from ARM Holdings.For example, an STM32 series microcontroller from ST MICROELECTRONICSmay be used.

Another processor suitable to control a RPT device 4000 in accordancewith a further alternative form of the present technology includes amember selected from the family ARM9-based 32-bit RISC CPUs. Forexample, an STR9 series microcontroller from ST MICROELECTRONICS may beused.

In certain alternative forms of the present technology, a 16-bit RISCCPU may be used as the processor for the RPT device 4000. For example aprocessor from the MSP430 family of microcontrollers, manufactured byTEXAS INSTRUMENTS, may be used.

The processor is configured to receive input signal(s) from one or moretransducers 4270, and one or more input devices 4220.

The processor is configured to provide output signal(s) to one or moreof an output device 4290, a therapy device controller 4240, a datacommunication interface 4280 and humidifier controller 5250.

In some forms of the present technology, the processor of the centralcontroller 4230, or multiple such processors, is configured to implementthe one or more methodologies described herein such as the one or morealgorithms 4300 expressed as computer programs stored in anon-transitory computer readable storage medium, such as memory 4260. Insome cases, as previously discussed, such processor(s) may be integratedwith a RPT device 4000. However, in some forms of the present technologythe processor(s) may be implemented discretely from the flow generationcomponents of the RPT device 4000, such as for purpose of performing anyof the methodologies described herein without directly controllingdelivery of a respiratory therapy. For example, such a processor mayperform any of the methodologies described herein for purposes ofdetermining control settings for a ventilator or other respiratoryrelated events by analysis of stored data such as from any of thesensors described herein. Similarly, such a processor may perform any ofthe methodologies described herein for purposes controlling operation ofany vent arrangement described in this specification.

4.4.2.4 Clock 4232

Preferably RPT device 4000 includes a clock 4232 that is connected toprocessor.

4.4.2.5 Therapy Device Controller 4240

In one form of the present technology, therapy device controller 4240 isa pressure control module 4330 that forms part of the algorithms 4300executed by the processor of the central controller 4230.

In one form of the present technology, therapy device controller 4240 isa dedicated motor control integrated circuit. For example, in one form aMC33035 brushless DC motor controller, manufactured by ONSEMI is used.

4.4.2.6 Protection Circuits 4250

Preferably a RPT device 4000 in accordance with the present technologycomprises one or more protection circuits 4250.

One form of protection circuit 4250 in accordance with the presenttechnology is an electrical protection circuit.

One form of protection circuit 4250 in accordance with the presenttechnology is a temperature or pressure safety circuit.

4.4.2.7 Memory 4260

In accordance with one form of the present technology the RPT device4000 includes memory 4260, preferably non-volatile memory. In someforms, memory 4260 may include battery powered static RAM. In someforms, memory 4260 may include volatile RAM.

Preferably memory 4260 is located on PCBA 4202. Memory 4260 may be inthe form of EEPROM, or NAND flash.

Additionally or alternatively, RPT device 4000 includes removable formof memory 4260, for example a memory card made in accordance with theSecure Digital (SD) standard.

In one form of the present technology, the memory 4260 acts as anon-transitory computer readable storage medium on which is storedcomputer program instructions expressing the one or more methodologiesdescribed herein, such as the one or more algorithms 4300.

4.4.2.8 Transducers 4270

Transducers may be internal of the device, or external of the RPTdevice. External transducers may be located for example on or form partof the air delivery circuit, e.g. the patient interface. Externaltransducers may be in the form of non-contact sensors such as a Dopplerradar movement sensor that transmit or transfer data to the RPT device.

4.4.2.8.1 Flow

A flow sensor 4272 in accordance with the present technology may bebased on a differential pressure transducer, for example, an SDP600Series differential pressure transducer from SENSIRION. The differentialpressure transducer is in fluid communication with the pneumaticcircuit, with one of each of the pressure transducers connected torespective first and second points in a flow restricting element.

In use, a signal representing total flow Qt from the flow sensor 4272 isreceived by the processor.

4.4.2.8.2 Pressure

A pressure transducer 4274 in accordance with the present technology islocated in fluid communication with the pneumatic circuit. An example ofa suitable pressure transducer is a sensor from the HONEYWELL ASDXseries. An alternative suitable pressure transducer is a sensor from theNPA Series from GENERAL ELECTRIC.

In use, a signal from the pressure transducer 4274 is received by thecentral controller processor. In one form, the signal from the pressuretransducer 4274 is filtered prior to being received by the centralcontroller 4230.

4.4.2.8.3 Motor Speed

In one form of the present technology a motor speed signal is generated.A motor speed signal is preferably provided by therapy device controller4240. Motor speed may, for example, be generated by a speed sensor 4276,such as a Hall effect sensor.

4.4.2.9 Data Communication Interface 4280

In one preferred form of the present technology, a data communicationinterface 4280 is provided, and is connected to central controllerprocessor. Data communication interface 4280 is preferably connectableto remote external communication network 4282. Data communicationinterface 4280 is preferably connectable to local external communicationnetwork 4284. Preferably remote external communication network 4282 isconnectable to remote external device 4286. Preferably local externalcommunication network 4284 is connectable to local external device 4288.

In one form, data communication interface 4280 is part of processor ofcentral controller 4230. In another form, data communication interface4280 is an integrated circuit that is separate from the centralcontroller processor.

In one form, remote external communication network 4282 is the Internet.The data communication interface 4280 may use wired communication (e.g.via Ethernet, or optical fibre) or a wireless protocol to connect to theInternet.

In one form, local external communication network 4284 utilises one ormore communication standards, such as Bluetooth, or a consumer infraredprotocol.

In one form, remote external device 4286 is one or more computers, forexample a cluster of networked computers. In one form, remote externaldevice 4286 may be virtual computers, rather than physical computers. Ineither case, such remote external device 4286 may be accessible to anappropriately authorised person such as a clinician.

Preferably local external device 4288 is a personal computer, mobilephone, tablet or remote control.

4.4.2.10 Output Devices Including Optional Display, Alarms

An output device 4290 in accordance with the present technology may takethe form of one or more of a visual, audio and haptic unit. A visualdisplay may be a Liquid Crystal Display (LCD) or Light Emitting Diode(LED) display.

4.4.2.10.1 Display Driver 4292

A display driver 4292 receives as an input the characters, symbols, orimages intended for display on the display 4294 and converts them tocommands that cause the display 4294 to display those characters,symbols, or images.

4.4.2.10.2 Display 4294

A display 4294 is configured to visually display characters, symbols, orimages in response to commands received from the display driver 4292.For example, the display 4294 may be an eight-segment display, in whichcase the display driver 4292 converts each character or symbol, such asthe figure “0”, to eight logical signals indicating whether the eightrespective segments are to be activated to display a particularcharacter or symbol.

4.5 Communication and Data Management System

FIG. 7 depicts an example system 100 in which aspects of the disclosuremay be implemented. This example should not be considered as limitingthe scope of the disclosure or usefulness of the features describedherein. The system is compatible with, and processes data from, bothdiagnostic and therapy devices. As provided above, patient medicaldiagnostic device 101 may be any sleep testing device used in connectionwith diagnosis of the patient's sleep-related breathing disorder.Therapy device 105 may be any device used in connection with providingtherapy for the patient's sleep-related breathing disorder. Thediagnostic device 101 and therapy device 105 may each include the RPTdevice 4000, humidifier 5000, and patient interface 3000 describedherein. Thus, when receiving data from a medical device, the system maybe configured to not only associate the received medical device datawith a corresponding patient record, but also determine whether thereceived medical device data is diagnostic usage data or therapy usagedata and update the patient records accordingly, based on predeterminedone or more criteria. The data identification may be associated with thedata itself or with a device ID from which it is received. If themedical device data is determined as diagnostic data, the system may beconfigured to process the diagnostic data and to generate a diagnosticreport and/or a prescription based on predetermined analysis criteria.The system may be further configured to display the diagnostic reportand/or the prescription to a diagnostic provider for review and toenable an electronic transfer of a diagnosis report or a therapyprescription, based on the diagnostic data, to a therapy provider.

System 100 has the ability to seamlessly transfer a patient's healthinformation (including demographic and medical data) directly fromdiagnosis through to patient therapy within the same system within asingle patient record. To facilitate this workflow, system 100 may havethe following functional features:

The ability to upload and analyse therapy management data within thesame software system as the diagnostic data, allowing for a singlesoftware system for both diagnostic and therapy management users. Thismay be helpful in avoiding formatting problems when transitioningbetween different software applications.

The ability to share the patient's diagnostic record with therapymanagement users, thus enabling them to save a patient's therapy andcompliance data directly to the common patient record having thepatient's diagnostic report and prescription data.

The ability of therapy provider to access the diagnostic data, as wellas therapy settings information from the initial prescription data, assaved in the patient's record, or even for the therapy device to beautomatically configured via a cable connection, wireless connection, ora memory card, by accessing this record.

As the patient uses medical diagnostic device 101, diagnostic data 111may be recorded on a storage medium, also referred to as memory, 112.Diagnostic data 111 may include any data relating to the patient's sleeptest, such as date, time and duration of test, as well as physiologicaldata obtained during the test, such as recorded respiratory flow data,respiratory effort data, oximetry and pulse data, or other clinicalinformation. Memory 112 may be of any non-transitory type capable ofstoring information accessible by a processor, including acomputer-readable medium, or other medium that stores data that may beread with the aid of an electronic device, such as a hard-drive, memorycard, ROM, RAM, DVD or other optical disks, as well as otherwrite-capable and read-only memories.

Server 201 includes a processor 210 and a memory 220 for storing data230 and instructions 234. Memory 220 stores information accessible byprocessor 210, including instructions 234 that may be executed orotherwise used by the processor 21. The memory 220 may be of anynon-transitory type capable of storing information accessible by theprocessor, including a computer-readable medium, or other medium thatstores data that may be read with the aid of an electronic device, suchas a hard-drive, memory card, ROM. RAM, DVD or other optical disks, aswell as other write-capable and read-only memories. Systems and methodsmay include different combinations of the foregoing, whereby differentportions of the instructions and data are stored on different types ofmedia.

The instructions 234 may be any set of instructions to be executeddirectly (such as machine code) or indirectly (such as scripts) by theprocessor. For example, the instructions may be stored as computer codeon the computer-readable medium. In that regard, the terms“instructions” and “programs” may be used interchangeably herein. Theinstructions may be stored in object code format for direct processingby the processor, or in any other computer language including scripts orcollections of independent source code modules that are interpreted ondemand or compiled in advance. Functions, methods and routines of theinstructions are explained in more detail below. Instructions 234 mayalso contain instructions for operating one or more virtual servers,such as Communication (Comm) server 240, Easy Care Online (ECO) Server250, and Communication Abstraction Layer (CAL) server 260.

The Communications Server (Comm) is responsible for communicating withwireless Therapy Devices and validating their output. The CommunicationsServer's core responsibilities may include, communicating with FlowGenerators via a Communication Module or inbuilt Communications Device;validating the incoming wireless data; and converting the wireless datainto a format which can be read by the CAL server.

The CAL server is responsible for communicating with Therapy Devices.The CAL server's core responsibilities may include, obtaining dailysummary data for active patients; retrieving and changing therapy devicesettings; and converting raw therapy device data into an easilydigestible format.

The ECO Server is responsible for application functionality within thesystem. The ECO Server's core responsibilities includes, presentingpatient and device information within the user interface, and writingand managing patient health information; and running application relatedprocesses.

The data 230 may be retrieved, stored or modified by processor 210 inaccordance with the instructions 234. For instance, although the systemand method is not limited by any particular data structure, the data maybe stored in computer registers, in a relational database as a tablehaving a plurality of different fields and records, XML documents orflat files. The data may also be formatted in any computer-readableformat. The data may comprise any information useful in identifying therelevant information, such as numbers, descriptive text, proprietarycodes, references to data stored in other areas of the same memory ordifferent memories (including other locations accessible through othernetwork connections) or information that is used by a function tocalculate the relevant data. Data 230 may include one or more databases,including a Comm database 231. CAL database 232, ECO database 233, andHST database 235. Various types of data may be saved in these databases.For example, the Comm, database 231, CAL database 232 and the ECOdatabase 233 may store data associated with the respective servers, asdescribed above. The HST database may store diagnostic data receivedfrom diagnostic devices 101.

The processor 210 may be any conventional processor, includingcommercially available processors. Alternatively, the processor may be adedicated device such as an ASIC or FPGA. Although FIG. 2 functionallyillustrates the processor, memory, and other elements of server 201 asbeing within the same block, it will be understood by those of ordinaryskill in the art that the processor and memory may actually comprisemultiple processors and memories that may or may not be stored withinthe same physical housing. For example, memory may be a hard drive orother storage media located in a housing different from that of server201. Accordingly, references to a processor or computer will beunderstood to include references to a collection of processors orcomputers or memories that may or may not operate in parallel or even belocated at the same site. Rather than using a single processor toperform the steps described herein some of the components such assteering components and deceleration components may each have their ownprocessor that only performs calculations related to the component'sspecific function. Thus, server 201 may be referred to as both a systemand an apparatus.

Computers 102, 103 and 104 may include all of the components normallyused in connection with a computer, such as a central processing unit(CPU), memory (e.g., RAM and internal hard drives) for storing data 120and 121 and instructions 130 and 131 (e.g. a web browser for displayingwebpages in HTML and a portable document format (PDF) reader), anelectronic display 110 and 115 (e.g., a monitor having a screen, a smallLCD touch-screen or any other electrical device that is operable todisplay information), and user input 160 and 161 (e.g., a mouse,keyboard, touch screen, and/or microphone).

The memory 112 may be internal to diagnostic device 101 which may beaccessed by connecting an USB data cable to a separate computer.Accordingly, the term “medical device” in such a case may be interpretedbroadly to include a personal computer, such as a desktop or mobilecomputer, which contains usage data, including diagnostic data 111collected from a medical device, such as a home sleep testing device. Inaddition, while FIG. 2 illustrates server 201 and computers 101-104 asbeing connected via a network 150, each two or more devices withinsystem 100 may be connected via a separate network or via the Internet.

In one example, any one of the ECO server 250 and its associated ECOdatabase 233, the Comm server 240 and its associated Comm database 231and the CAL server 260 and its associated CAL database 232 may reside ona device at a location that is remote from the remaining servers. Inaddition, at least two of these servers, such as the Comm server 240,Comm database 231, CAL server 260, and CAL database 232, may exist on asingle device.

4.6 Example Methods

In order for a patient to undergo a test, the patient may need to beissued with a diagnostic order by the patient's treating physician. Thepatient is referred to a sleep test where the patient may be issued adiagnostic device 101 for sleep testing. The diagnostic device 101 maycollect any one of the following types of data Polysomnography (PSG)data, polygraphy data, oximetry data, pneumatic or RespiratoryInductance Plethysmography (RIP)-based respiratory effort data,respiratory flow data, audio signal data, body position data etc.

The patient's record is first created during the diagnostic stage, whenthe patient is approved for running a diagnostic test. The patient'srecord may comprise any data that is associated with the patient or withthe patient's condition, such as the patient's personal details (name,gender, age, address, contact details etc.), symptoms, treatingphysician, insurance provider, type of insurance cover etc. Fromdiagnostic provider's computer 104, where the patient's record iscreated, it is transferred to the ECO database of server 201. It shouldbe appreciated that computer 104 may not be a personal computer, but anadministration computer used at the diagnostic provider clinic. As such,this computer may be operated, at least partially, not by the specificdiagnostic physician responsible for the testing and diagnosis of therespective patient, but by a data administrator on the site. Forexample, it can be envisaged that such an administrator may beresponsible for creating the patient's record.

During the actual test, the diagnostic device collects diagnostic dataindicating any respiratory condition that the patient may have, as wellas other information, such as the type and model of the diagnosticdevice, the patient's details, including these of the referringdiagnostic physician, time and dates of usage etc.

During the actual test, the diagnostic device saves the diagnostic testdata 111 in memory 112. A user of system 100, such as a user ofdiagnostic provider computer 104, may have a remote access to the memory112 of the medical diagnostic device 101. Alternatively, user ofdiagnostic provider computer 104 may extract the portable memory card ofdevice 101 and download the data to computer 104. An addition, one canconnect the device 101. e.g. via a USB cable, to the diagnostic providercomputer 104 to access the device memory 112. A web browser 131 on thediagnostic provider computer 104 may then be used to contact server 201and upload diagnostic data 111 to one or more of the databases 231, 232,233 and 235.

The diagnostic data 111 provided to server 201 from diagnostic device101 may be stored in a CAL database 232, which may identify the type ofpatient device from which it came. For example, each diagnostic device101 may be assigned a device ID, which is provided to server 201 alongwith the diagnostic data. The diagnostic data may then be stored byserver 201 in a database that uses the device ID to associate thereceived data with the appropriate patient diagnostic device 101. Theusage data from therapy device 105 may be processed in a similar manner.

In some instances, a patient is required to use a medical diagnosticdevice for a set duration and exhibit certain clinical symptoms in orderto be eligible to qualify for therapy of the patient's sleep disorderbreathing. For example, a patient who has been ordered a home sleep testmay be required to use the diagnostic device for at least four hours andexhibit an Apnea-Hypopnea Index (AHI) of greater than 5 in order for aphysician to write a prescription for CPAP therapy. The prescription(also referred to as prescription data or prescription information) maybe saved in the HST database 235). System 100 may be used to trackwhether the patient has been compliant in using the diagnostic deviceand may assist a physician in making a diagnosis.

Once the patient is tested, a diagnosis may be issued by the sleepprovider and may be based on the diagnostic information produced bysystem 100, and more specifically by the testing/diagnostic device 101.Depending on the patient's diagnosis, a diagnostic provider, and morespecifically a diagnostic physician, may issue a prescription fortherapy. The diagnostic provider may input his or her clinicalinterpretation of diagnostic data into the patient's record. Inaddition, the ECO database may contain a list of clinical options for anumber of therapy devices 105 which the diagnostic physician may assignto a patient, as they see appropriate. In assigning these devices, ECOserver 250 may select the appropriate pre-set of settings from the ECOdatabase and then allow the diagnostic provider to input the clinicalvalues into the appropriate fields. The data corresponding to thepatient and device type may then be stored on server 201, such as in theECO database 233.

In some cases, the testing compliance criteria is usually defined by thereimbursing authority and may be set in the system 100 by a user, suchas the sleep physician or clinician in the diagnostic site (a user ofdiagnostic computer 104). For example, usage data from diagnostic device101 may demonstrate that a patient was tested for at least 4 hours andhad an Obstructive Sleep Apnea with an AHI of 20, and therefore may be acandidate for CPAP therapy. A qualified healthcare professional, such asa sleep physician, may use computer 104 to write a prescription within aweb browser 131 for therapy for a CPAP device at a pressure of 14 cmH20.Diagnostic computer 104 may transmit the prescription data to server201, wherein it will be stored in a database, such as in the ECOdatabase 233, to become a part of the patient's record.

Patients prescribed for therapy will need to open new records with theirdiagnostic provider, e.g. on diagnostic computer 104. Instead, theproposed system allows access to their record, including any usage andsettings data, to a therapy provider computer 102 so that the patientscan be supplied and set up with a therapy device. For example, thepatient diagnosed with Obstructive Sleep Apnea will need to have theirpatient information and prescription sent to an assigned therapyprovider who can supply them with a CPAP device. System 100 may be usedto facilitate the assignment, access, and transfer of data from thediagnostic provider to a trusted therapy provider. Instead of creating anew patient record, the patient's record may be electronicallytransferred. Furthermore, instead of transferring the patient record,the system may allow the therapy provider to access the present patientrecord, as created and updated during the diagnostic stage. Depending onthe arrangement, the therapy provider may be allowed access either tothe entire patient record, or only to some of the patient identificationdata, diagnostic data, diagnostic report, therapy prescription andinitial device setting data. Also, the access to the respective data maybe open access with full functionality, or only limited access. Such alimited access, for example, may involve the capability to view and/ordownload the diagnostic data, but not to modify it.

The therapy provider may be allowed to modify the access of thediagnostic provider. For example, after the record is made accessible tothe therapy provider, the therapy provider may allow continuous accessby the diagnostic provider to the patient's record. Depending on thearrangement, the diagnostic provider may be allowed access either to theentire patient record, or only to some of the patient data, such as thepatient's identification data, diagnostic data, but not to the patient'stherapy data. Also, the access to the respective data may be open accesswith full functionality, or only limited access. Such a limited access,for example, may involve the capability to view and/or download thetherapy data, but not to modify it.

Thus, once the electronic patient record is created, medicalpractitioners associated with either the diagnostic stage or the therapystage may be provided various level of access to the electronic patientrecord during both the diagnostic stage and the therapy stage.

A health care professional at a diagnostic provider location may monitorthe status of their patient's diagnostics data and forward theirprescription to a therapy provider by contacting server 201 via awebsite accessed on diagnostic computer 104. For example, the healthcareprofessional may access patient data via webpage 800 (the ‘dashboard’)shown in FIG. 8. Webpage 800 may contain a list of active patients whoare currently proceeding through home sleep testing, including statusindicators that indicate the status of the patient's diagnostic tests.The various icons indicate the different status of the patient. Forexample—the bed-like icons indicate that the patient is still in testingphase. The physician profile-like icon indicates that the patient hasmoved to the diagnostic report phase. Different colour, for example, maybe used to indicate whether the report has or has not being issued yet.Similarly, the Rx icon indicates that the patient's diagnostic report isready and the patient has moved to the prescription stage. Again,different colour may be used to indicate whether the prescription has orhas not being issued yet. Finally, icon 871 may indicate that thepatient is in the “patient record being finalised” phase.

As shown in FIG. 9, the patient Noemy Harber has completed her testing,diagnostic report and prescriptions stages. The icon Rx indicates thatNoemy's diagnostic report and prescription are ready. As indicated bystatus indicator 872, the patient's record has undergone even the finalchecks and is now ready to be sent. Such final checks may involveverification of the patient's name, phone number and insurance providerdetails.

Once a diagnostic provider associated with diagnostic computer 104 hasdetermined that the patient needs to go onto therapy, the diagnosticprovider may click on the icon 871. As shown in FIG. 9, pop-up window973 may appear when icon 871 is selected. Pop-up window 973 may then beused to send patient information to a selected therapy provider that isto be associated with the therapy of the patient. The diagnosticprovider may select a particular therapy provider from a list of therapyproviders using drop-down menu 974. For that purpose, the diagnosticprovider computer 104 may send a transmission to the ECO serverrequesting data for available therapy providers within the system oftherapy providers. ECO server will then provide data responsive to therequest, which will populate menu 974 within the web browser 131. Byclicking on send button 976 the healthcare professional can instantlyconfirm their choice and initiate a command to the ECO server totransfer ownership of the patient record to the therapy providernominated in menu 974. Clicking on send button 976 transfers ownershipof the patient to the therapy provider and changes the status of thepatient within the dashboard to “Results Sent.” In this way, healthcareprofessionals may quickly and easily transfer their patients directlyinto the therapy provider's inbox without having to manually transferpaper records via fax, mail or via the patient.

In some instances. ECO server 250 may automatically provide therapyprovider computer 102, by way of web browser (e.g. instructions 130) andvia the network 150, with the usage and therapy settings data requiredto set up a patient on therapy device 105 as directed by the diagnosticprovider physician's prescription. For example, a therapy provider maybe notified by the ECO server 250 when a diagnosis and prescription fortherapy has been created on the server by a diagnostics provider andassigned to them. This allows the therapy provider to be immediatelyinformed of a patient's transfer into their care and ensures that apatient is supplied with the correct therapy device having the requiredtherapeutic settings. The settings data can be automatically transferreddirectly to therapy device 105, such as via an internet connection, ormanually inputted via an SD card or the therapy device's interface.

A therapy provider may be automatically alerted that a patient has beenreferred to them by messaging service, such as E-mail or SMS messaging,or by contacting therapy provider computer 102 via server 201. Forexample, the therapy provider or an administrator at the therapyprovider's office may access the transferred patient informationdescribed above via webpage 900 shown in FIG. 10. Webpage 900 maycontain various data items, such as patient names 970, referringdiagnostic providers 982, contact details 983, diagnostic andprescription information 984, insurer data 986, an acceptance status987, or any other patient information of interest. A therapy providermay use webpage 900 to accept or reject a patient referral. For example,the therapy provider may select a patient having an “accept/reject”status, and then designate the patient's referral as either “accepted”or “rejected.” Once the therapy provider has accepted the desiredpatient, the therapy provider computer 102 may send a transmission tothe ECO server requesting additional patient health information from theECO database for the relevant patient ID. ECO server will then providepatient demographic and therapy settings data responsive to the request,which once available will be used to pre-populate data fields requiredfor a setup of the new patient with a therapy device. Thus, the systemis configured to dynamically update the therapy provider's availablepatient list the record of the new patient, as well as to startdisplaying the additional patient record in the patient list of thetherapy provider. For example FIG. 11 shows webpage 910 in which thepatient Noemy Harber may be automatically assigned various therapydevices in accordance with her prescription. The healthcare professionalmay alter the assigned devices or identify additional therapy devices orcomponents in field 1102 and have those devices or components assignedto the patient by selecting the Add icon 1104.

As shown in FIG. 10, Noemy Harber's patient record details are nowvisible to the administrative staff using therapy provider computer 102.After contacting the patient, such as by the website, e-mail, or phone,the administrator may schedule a time for a therapy provider to meetwith the patient. For example, the administrator may click on Accept anduse dialogue box 985 to assign the patient to a clinical user andtransfer the new patient into the therapy provider's work queue. Thetherapy provider's work queue is shown in FIG. 12 as webpage 920. Thework queue webpage may show compliance icons 1202 and noncomplianceicons 1204 to indicate whether a patient is currently compliant with hisor her prescribed therapy. The work queue may also indicate the lasttime the compliance data was updated, as well as statistics regardingthe patient's usage of the therapy device. The work queue of webpage 920may be securely accessed by a clinician, an administrator, or both.Secure access may include some form of protection to preventunauthorized individuals from access patient data. For example, server201 of FIG. 7 may require a password before transmitting patient data.Server 201 may also encrypt the transmitted data so as to preventunauthorized devices from displaying the data.

A healthcare professional may also assign and configure Noemy Harber'stherapy device via webpage 920 shown in FIG. 12, and set her up forongoing monitoring by clicking on her name and opening the patientrecord shown in FIG. 13 as webpage 930. As seen on webpage 930 withinthe patient record section, the patient information required to set up apatient for ongoing monitoring may be already pre-populated from the ECOdatabase 233 with any patient data available from the diagnosticprovider including patient demographics, insurance information anddevice therapy settings. As described above, a prescribed CPAP therapydevice with a humidification unit is may be automatically assigned tothe patient. In this way, healthcare professionals may quickly andeasily set up patients on therapy without having to re-enter the patientdata manually from paper prescriptions as well as reducing thepercentage of patient who fail to present at the therapy provider fortherapy. All therapy notes, prescriptions, and diagnostic reports may beviewed within the notes section of the patient record as shown inwebpage 940 of FIG. 14.

Returning to FIG. 7, a therapy healthcare professional who accessesserver 201 via therapy provider computer 102 may provide diagnostic andcompliance summary reports, which have been generated by server 201, tothe respective assessing entities. This can be performed by transmittingthe diagnostic and/or compliance reports from therapy provider computer102 to an external party, such as the reimbursing entity computer 103,via network 150. The diagnostic and/or compliance reports may betransmitted in any number of ways, including as part of an E-mailtransmission. Alternatively, the diagnostic and/or compliance reportsmay be saved either at therapy provider computer 102 or server 201 andthe assessing entity may send, via the reimbursing entity computer 103,a request for diagnostic and/or compliance reports to either computer102 or server 201.

FIG. 15 provides a schematic representation for the system and methodsdescribed above. As seen in FIG. 15, a single patient record may becreated, saved to a single data platform, updated and accessed by usinga single software system, regardless of whether the patient is thediagnostic or the therapy stage of the patient management. In addition,the data platform may reside on multiple remote servers or on a singlephysical system of servers so as to allow for integrated electronicmanagement of data relating to both the diagnostic stage and therapystage. Medical practitioners from both the diagnostic management stageand the therapy management stage may be provided access to this recordand can save and access relevant data associated with at least one ofgeneral patient data, diagnostic data, device usage data, compliancedata, device parameters, diagnostic report, device prescription etc.This reduces the time and effort involved in creating multiple records,as well as minimises the likelihood of errors. The described system hasthe following features:

The capability to download to, upload from, view and analyse diagnosticdata within the same software management tools and, in some cases,physical set of servers, as the therapy management stage data. Thismakes it much more convenient for both the diagnostic providers and thetherapy providers, as they have a single point of access to thepatient's data and do not need to use two different data platforms, havetwo different passwords etc. Here the term data platform is used broadlyin relation to at least one of the hardware setup and the used software.The service providers from the reimbursement entity 103 also need toaccess both the diagnostic and the therapy data of the patient toevaluate whether the patient is compliant with the prescribed diagnosticor therapy requirements. Thus, they also benefit from the singlepassword, the single point of entry and the use of a single dataplatform used for accessing both types of data.

The capability to upload diagnostic data, diagnostic reports,prescription information, as well as a therapy device usage andcompliance data, directly into the original patient's therapy recordcreated and populated in the diagnostics data management stage.

The capability to send device settings data from a prescription issuedby a sleep physician directly to the diagnostic patient record, where itcan be accessed and downloaded by the therapy provider without the needof manual rewriting or electronic re-creating of the record. Thiscontrasts with the current practice of the patient having to personallytake their prescription to the therapy provider or, at best, thediagnostic provider faxing or otherwise transferring the prescription tothe therapy provider who then has to read the prescription and manuallyinput the settings into the device. The proposed system allows thediagnostic provider to save the prescription in the patient record fromwhere it is directly accessed by the therapy provider. Those settingscan also be automatically downloaded to a card or sent wirelessly to thedevice upon device setup.

4.7 Other Remarks

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular examples, it is to be understood that these examples aremerely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative embodiments and that other arrangements may bedevised without departing from the spirit and scope of the technology.

The invention claimed is:
 1. A method for patient data processing duringdiagnosis and therapy of sleep disorder breathing, the methodcomprising: generating, by one or more computing devices, an electronicpatient record for a patient; during a diagnostic stage of patientmanagement, storing, by the one or more computing devices, diagnosticdata in the electronic patient record; providing, by the one or morecomputing devices, a diagnostic provider with access to the electronicpatient record; during a therapy stage of patient management, providing,by the one or more computing devices, a therapy provider with access tothe electronic patient record, wherein the therapy stage is discretefrom the diagnostic stage; and updating, by the one or more computingdevices, the electronic patient record to include therapy data; whereinproviding the diagnostic provider with access to the electronic patientrecord comprises providing a user interface that presents; (a) aplurality of different patient status icons, wherein each patient statusicon represents a different sequential phases of a patient status alongthe diagnostic stage and the user interface is configured to change iconpresentation to represent each patient status icon in correspondencewith whether the patient status is in or has completed a respectivesequential phase corresponding to the patient status icon, wherein theuser interface presents a completion icon of the plurality of patientstatus icons if the patient status is in a patient record finalizationphase of the different sequential phases, and (b) a selector forselecting a therapy provider from a plurality of therapy providerselections, the selector presented for selection upon selection of thecompletion icon, and wherein the selector enables an electronic transferof at least one of a diagnostic report and a therapy prescription to thetherapy provider selected from the plurality of therapy providerselections.
 2. The method of claim 1, wherein the method furthercomprises storing reports and prescriptions, generated during either thediagnostic stage or the therapy stage, in the electronic patient record.3. The method of claim 1, wherein the method further comprises, when thediagnostic stage is at an end, electronically notifying the therapyprovider of a new patient; and providing the therapy provider withaccess to at least one of diagnostic data and prescription data of thenew patient.
 4. The method of claim 1, wherein therapy settings from atherapy prescription are retrieved from the electronic patient recordand used to automatically configure a therapy device for the patient. 5.The method of claim 1, wherein providing the therapy provider withaccess to the electronic patient record further comprises dynamicallyupdating a patient list of the therapy provider based on a therapyselection provided to the user interface.
 6. The method of claim 1,wherein storing the electronic patient record during the diagnosticstage and updating the electronic patient record during the therapystage are performed on a single data platform.
 7. The method of claim 1,wherein storing the electronic patient record during the diagnosticstage and updating the electronic patient record during the therapystage is performed on a single physical system of servers.
 8. The methodof claim 1, wherein, once the electronic patient record is created,medical practitioners associated with either the diagnostic stage or thetherapy stage are provided access to the electronic patient recordduring both the diagnostic stage and the therapy stage.
 9. The method ofclaim 1, wherein the diagnostic stage comprises receiving data from adiagnostic device and the therapy stage comprises receiving data from atherapy device, the therapy device being a flow generator forrespiratory therapy.
 10. An electronic system for integrated managementof diagnostic and therapy data of a plurality of sleep disorderbreathing patients; one or more memories configured to store anelectronic patient record comprising patient data; one or moreprocessors in communication with the one or more memories, the one ormore processors configured to: receive and store diagnostic data in theelectronic patient record and provide a diagnostic provider with accessto the electronic patient record during a diagnostic stage of patientmanagement; and receive and store therapy data in the electronic patientrecord and provide a therapy provider with access to the electronicpatient record during a therapy stage of patient management, wherein thetherapy stage is discrete from the diagnostic stage; wherein providingthe diagnostic provider with access to the electronic patient recordcomprises providing a user interface that presents: (a) a plurality ofdifferent patient status icons, wherein each patient status iconrepresents a different sequential phase of a patient status along thediagnostic stage and the user interface is configured to change iconpresentation to represents each patient status icon in correspondencewith whether the patient status is in or has completed a respectivesequential phase corresponding to the patient status icon, wherein theuser interface presents a completion icon of the plurality of patientstatus icons if the patient status is in a patient record finalizationphase of the different sequential phases, and (b) a selector forselecting a therapy provider from a plurality of therapy providerselections, the selector presented for selection upon selection of thecompletion icon, and wherein the selector enables an electronic transferof at least one of a diagnostic report and a therapy prescription to thetherapy provider selected from the plurality of therapy providerselections.
 11. The electronic system of claim 10, wherein at least oneof the one or more processors are configured to store reports andprescriptions, generated during either the diagnostic stage or thetherapy stage, in the electronic patient record.
 12. The electronicsystem of claim 10, wherein when the diagnostic stage is at an end, atleast one of the one or more processors is configured to enable sendingof a notification to the therapy provider and provide access for thetherapy provider to at least one of diagnostic, prescription and therapydata of the patient.
 13. The electronic system of claim 10, wherein atleast one of the one or more processors is configured to retrievetherapy settings from a therapy prescription of the electronic patientrecord and use it to automatically configure a patient's therapy device.14. The electronic system of claim 13, wherein the automaticconfiguration is effected by way of a network connection or a memorycard.
 15. The electronic system of claim 10, wherein the electronicsystem is configured to operate on a single data platform during boththe diagnostic stage and the therapy stage, and wherein at least one ofthe one or more processors is configured to receive therapy data from apatient's therapy device during the therapy stage.
 16. The electronicsystem of claim 10, wherein the electronic system comprises one or moreservers configured to process data from both the diagnostic stage andthe therapy stage.
 17. The electronic system of claim 10, wherein, oncethe electronic patient record is created, at least one of the one ormore processors is configured to provide a provider associated witheither the diagnostic stage or the therapy stage, with access to theelectronic patient record during the diagnostic stage and the therapystage.
 18. The electronic system of claim 10, wherein the at least oneof the one or more processors is configured to process data from adiagnostic device, during the diagnostic stage, and from a therapydevice, during the therapy stage, the therapy device being a flowgenerator used for respiratory therapy.
 19. A method for providingdiagnosis and therapy of sleep disorder breathing, the methodcomprising: receiving, by one or more computing devices, medical devicedata for a plurality of patients; storing, by the one or more computingdevices, the medical device data; determining, by the one or morecomputing devices, whether to process the medical device data asdiagnostic data or as therapy data, based on a predetermined criterionrelated to identification data of the medical devices; if the medicaldevice data is determined as diagnostic data, generating, by the one ormore computing devices, diagnostic information based on predeterminedanalysis criteria, enabling, by the one or more computing devices, anelectronic transfer of at least one of a diagnostic report and a therapyprescription to a therapy provider, wherein any one of the diagnosisreport and the prescription is based on the diagnostic data, theenabling comprising generating a user interface that presents: (a) aplurality of different patient status icons, wherein each patient statusicon presenting represents a plurality of different sequential phases ofa patient status along a diagnostic stage and the user interface isconfigured to change icon presentation to represent each patient statusicon in correspondence with whether the patient status is in or hascompleted, a respective sequential phase corresponding to the patientstatus icon, wherein the user interface presents a completion icon ofthe plurality of patient status icons if the patient status is in apatient record finalization phase of the different sequential phases,and (b) a selector for selecting the therapy provider from a pluralityof therapy provider selections, the selector presented for selectionupon selection of the completion icon; and transmitting, by the one ormore computing devices, therapy settings to a therapy device, thetherapy settings being associated with at least one of the diagnosisreport and the prescription.
 20. The method of claim 19, whereinreceiving the medical device data further comprises receiving a signalthat, one of the medical device has data available for uploading. 21.The method of claim 19, wherein the medical device is a home sleeptesting device or a flow generator used for respiratory therapy.
 22. Themethod of claim 19, wherein a generated diagnostic report: containssummary statistics of the diagnostic data; and provides an area where adiagnostic provider may input their clinical interpretation when any oneof the diagnosis report and the prescription is displayed to thediagnostic provider for review.
 23. The method of claim 22, wherein thediagnostic report comprises a prescription for therapy that identifiesone or more therapy devices and one or more therapeutic settings to beused by the respective patients.
 24. The method of claim 19, wherein adiagnostic report is displayed as HTML, on a web browser or as aPortable Document Format (PDF).
 25. The method of claim 19, the methodcomprising: enabling assigning of a therapy provider to a patient thatis ready for therapy; transferring or allowing access to diagnostic datafor the patient to the assigned therapy provider; and electronicallyimporting therapy settings from the diagnostic data onto the therapydevice to be used by the patient.
 26. An apparatus for integratedelectronic management of diagnostic and therapy data of a plurality ofsleep disorder breathing patients, the apparatus comprising: a memoryconfigured to store medical data; and one or more processors incommunication with the memory, the one or more processors configured to:receive medical device data for a plurality of patients; associate thereceived medical device data with a corresponding patient record;determine whether the received medical device data is diagnostic ortherapy usage data; update the patient records in accordance with thedetermination of whether the received medical device data is diagnosticor therapy usage data, and generate a user interface that presents: (a)a plurality of different patient status icons, wherein each patientstatus icon represents a different sequential phase of a patient statusalong a diagnostic stage and the user interface is configured to changeicon presentation to represents each patient status icon incorrespondence with whether the patient status is in or has completed arespective sequential phase corresponding to the patient status icon,wherein the user interface presents a completion icon of the pluralityof patient status icons if the patient status is in a patient recordfinalization phase of the different sequential phases, and (b) aselector for selecting a therapy provider from a plurality of therapyprovider selections, the selector being made selectablopresented forselection upon activation selection of the completion icon, wherein theselector enables an electronic transfer of at least one of a diagnosticreport and a therapy prescription to the therapy provider selected fromthe plurality of therapy provider selections.
 27. The apparatus of claim26, wherein the one or more processors are further configured to: storea list of therapy providers within a system of therapy providers; andreceive a request to display the list from a diagnostic provider. 28.The apparatus of claim 26, wherein the one or more processors arefurther configured to: receive diagnostic data from a plurality ofmedical devices; generate summary statistics by processing thediagnostic data using a set of predetermined analysis criteria; receivea request generated by a diagnostic provider; and transmit, in responseto the request, a diagnostic report comprising the summary statistics.29. The apparatus of claim 26, wherein the one or more processors arefurther configured to: store a diagnostic report; store a prescriptioncomprising a selection of at least a therapy device and therapy devicesettings; store a note generated by a diagnostic provider; and transmitthe diagnostic report, the prescription and the note to a selectedtherapy provider.
 30. The apparatus of claim 29, wherein the one or moreprocessors are further configured to: allow access to diagnostic dataand/or prescription data of a patient record to the selected therapyprovider; dynamically update a list of patients available to theselected therapy provider with at least one new patient record; anddisplay the new patient record in the list of patients.
 31. Theapparatus of claim 26, wherein the one or more processors are furtherconfigured to: display patient information and a prescription fortherapy as selected by a therapy provider; receive a request to assign apatient with a therapy device ID that corresponds to the prescription;and automatically transfer clinical settings information from theprescription into a memory of the therapy device.
 32. The method ofclaim 1 wherein the plurality of different patient status icons furthercomprises any two or more of: a testing phase, a diagnostic reportphase, and a prescription phase.
 33. The method of claim 19 wherein theplurality of different patient status icons further comprises any two ormore of: a testing phase, a diagnostic report phase, and a prescriptionphase.
 34. The electronic system of claim 10 wherein the plurality ofdifferent patient status icons further comprises any two or more of: atesting phase, a diagnostic report phase, and a prescription phase.